The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are: Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function? Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.
UCHealth Rehabilitation Unit
Aurora, Colorado, United States
RECRUITINGBroomfield Hospital
Broomfield, Colorado, United States
RECRUITINGChange in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66.
Time frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants with at least one adverse event
Adverse event will only include those that are determined to be related to the vibrotactile stimulation
Time frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who completed the therapy
Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy
Time frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who tolerated the vibrotactile stimulation therapy
Therapy tolerability will be assessed by responses to questionnaires
Time frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Change in the modified Ashworth scale
The modified Ashworth scale is used to assess spasticity and tests the resistance to passive movement about a joint with varying degree of velocity. The modified Ashworth scale assigns a grade of spasticity from a 0-4 ordinal scale
Time frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
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